A Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation

NCT00601432 | Completed Phase 1

• 1 other identifier: CR010621
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of the study was to evaluate the effect of food on the single-dose pharmacokinetics of an oral solution of levofloxacin.

Conditions

Healthy

Keywords

open-label; randomized; crossover; food effect

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effect of food on the single-dose pharmacokinetics of an oral solution of levofloxacin at 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 10, 14, 24, 30, 36, and 48 hours after dosing.

Secondary Outcomes (1)

• Safety was assessed through vital sign monitoring, physicals, laboratory tests, and urinalysis on Days 1 and 3 and through the monitoring of adverse events throughout the study.

Interventions

levofloxacin oral solution DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women
• Aged 18 to 55 years
• BMI between 18 and 30 kg/m2
• No prescription or over-the-counter medication for previous 14 days
• Negative tests for drug and alcohol abuse
• HIV, hepatitis B and hepatitis C
• and Healthy based on medical history, physical examination, 12-lead electrocardiograms, toxicology, antigen, antibody screens, and clinical laboratory evaluations

You may not qualify if:

• Allergic reaction to quinolones
• clinically significant ECG or clinical laboratory abnormalities
• creatinine clearance \<=80 mL/min
• acute illness within 7 days
• receipt of experimental drug or device within 60 days
• pregnant or breastfeeding

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• An open-label, randomized, 2-way crossover study to evaluate the effect of food on levofloxacin pharmacokinetics from an oral solution formulation

MeSH Terms

Interventions

Levofloxacin

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: January 28, 2008
• Study Start: October 1, 2002
• Study Completion: December 1, 2002
• Last Updated: December 22, 2016

Record last verified: 2010-04